MAUDE Adverse Event Report: SYNTHES GMBH 2.0 RAPID RESRB OBL L-PL 6H X 4H/RT-S; PLATE, BONE

Catalog Number	852.264.01S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: tomomatsu n, takahara n, akaike y, sato y, kurasawa y, yoda t.Postoperative stability of bioresorbable plates made of 85:15 poly (l-lactide-co-glycolide) in le fort i osteotomy.Oral surg oral med oral pathol oral radiol.2023 nov;136(5):569-576.Doi: 10.1016/j.Oooo.2023.04.016.Epub 2023 may 1.Pmid: 37640562.The study aimed to compare the postoperative stability of rapidsorb plates, rapidsorb combined with titanium (moj plates), and moj plates in patients who underwent le fort i osteotomy at tokyo medical and dental university hospital.The use of rapidsorb in the maxilla is a load-sharing application and therefore constitutes an approved indication.Discrepancies in the maxillary positions were measured using postoperative computed tomography data at 1 week and 1 year using the centroid method 3-dimensionally.Treatment with rapidsorb alone showed a more vertical discrepancy in the maxilla treatment with moj and rapidsorb+moj.The rapidsorb4 group was subdivided into 2 groups (under and over 1.0-mm) based on the change in the maxillary centroid.Between april 2018 and march 2021 were selected and evaluated retrospectively for cases using rapidsorb and titanium screws and plates.Lot, model and catalog number are not available, but the suspected depuy synthes device possibly associated with reported adverse events: rapidsorb plates (depuy synthes) made of 85.15 poly (l-lactide-co-glycolide) adverse event(s) and provided interventions possibly associated with unk - resorbable implants (qty 21) (n=20) patients in rap4 group had a poor stability, no intervention provided.(n=1) patient had a postoperative deviation by fixation with four rapidsorb plates is due to the tooth being somewhat vulnerable to occlusal loads, due to a decrease in the gripping strength of the screw caused by slight wobbling during tapping, no intervention provided.Adverse event(s) and provided interventions possibly associated with lot numbers were plate 6l87402, 6l71797, 6l58763, 6l39795 (qty 1) (n=1).A 24-year-old male had a plate fracture, in which a fracture fragment of rapidsorb was ejected from the wound 6 months after surgery.The fractured fragments have already been processed and are no longer present.There was no maxillary bone movement, and the patient had a good follow-up.Adverse event(s) and provided interventions possibly associated with lot number screw 4l95040 (qty 1) (n=1) a 24-year-old male had a plate fracture, in which a fracture fragment of rapidsorb was ejected from the wound 6 months after surgery.The fractured fragments have already been processed and are no longer present.There was no maxillary bone movement, and the patient had a good follow-up.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.Device history review: part:852.264.01s lot:6l87402 manufacturing site: werk bio oberdorf.Supplier: na.Release to warehouse date: 27 may 2020.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received states that none of the patients experienced adverse events such as maxillary sinusitis or obvious nonunion.There was one case of plate fracture.The lot numbers were plate 6l87402, 6l71797, 6l58763, 6l39795 and screw 4l95040.The fractured fragments have already been processed and are no longer present.The slight postoperative deviation by fixation with four rapidsorb plates is due to the tooth being somewhat vulnerable to occlusal loads, and we believe this is due to a decrease in the gripping strength of the screw caused by slight wobbling during tapping.

• Brand Name: 2.0 RAPID RESRB OBL L-PL 6H X 4H/RT-S
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20384210
• Report Number: 8030965-2024-12547
• Device Sequence Number: 7944270
• Product Code: JEY
• UDI-Device Identifier: 10887587064307
• UDI-Public: (01)10887587064307(17)230401(10)6L87402
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: 852.264.01S
• Device Lot Number: 6L87402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 65 KG